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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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3P Hip System - 00840194472920

90° Adolescent Offset Plate, 4-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-3964
In Commercial Distribution

  • 00840194472920 ()
00-3001-3964

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472913

90° Adolescent Offset Plate, 3-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-3963
In Commercial Distribution

  • 00840194472913 ()
00-3001-3963

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472906

110° Child Offset Plate, 5-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2125
In Commercial Distribution

  • 00840194472906 ()
00-3001-2125

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472890

110° Child Offset Plate, 4-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2124
In Commercial Distribution

  • 00840194472890 ()
00-3001-2124

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472883

110° Child Offset Plate, 3-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2123
In Commercial Distribution

  • 00840194472883 ()
00-3001-2123

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472876

110° Child Offset Plate, 5-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2165
In Commercial Distribution

  • 00840194472876 ()
00-3001-2165

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472869

110° Child Offset Plate, 4-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2164
In Commercial Distribution

  • 00840194472869 ()
00-3001-2164

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472852

110° Child Offset Plate, 3-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2163
In Commercial Distribution

  • 00840194472852 ()
00-3001-2163

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472845

90° Child Offset Plate, 5-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2925
In Commercial Distribution

  • 00840194472845 ()
00-3001-2925

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472838

90° Child Offset Plate, 4-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2924
In Commercial Distribution

  • 00840194472838 ()
00-3001-2924

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472821

90° Child Offset Plate, 3-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2923
In Commercial Distribution

  • 00840194472821 ()
00-3001-2923

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472814

90° Child Offset Plate, 5-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2965
In Commercial Distribution

  • 00840194472814 ()
00-3001-2965

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472807

90° Child Offset Plate, 4-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2964
In Commercial Distribution

  • 00840194472807 ()
00-3001-2964

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472791

90° Child Offset Plate, 3-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-2963
In Commercial Distribution

  • 00840194472791 ()
00-3001-2963

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472784

110° Infant Offset Plate, 4-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1124
In Commercial Distribution

  • 00840194472784 ()
00-3001-1124

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472777

110° Infant Offset Plate, 3-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1123
In Commercial Distribution

  • 00840194472777 ()
00-3001-1123

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472760

110° Infant Offset Plate, 2-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1122
In Commercial Distribution

  • 00840194472760 ()
00-3001-1122

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472753

110° Infant Offset Plate, 4-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1164
In Commercial Distribution

  • 00840194472753 ()
00-3001-1164

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472746

110° Infant Offset Plate, 3-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1163
In Commercial Distribution

  • 00840194472746 ()
00-3001-1163

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472739

110° Infant Offset Plate, 2-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1162
In Commercial Distribution

  • 00840194472739 ()
00-3001-1162

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472722

90° Infant Offset Plate, 4-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1924
In Commercial Distribution

  • 00840194472722 ()
00-3001-1924

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472715

90° Infant Offset Plate, 3-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1923
In Commercial Distribution

  • 00840194472715 ()
00-3001-1923

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472708

90° Infant Offset Plate, 2-Hole, 12mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1922
In Commercial Distribution

  • 00840194472708 ()
00-3001-1922

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472692

90° Infant Offset Plate, 4-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1964
In Commercial Distribution

  • 00840194472692 ()
00-3001-1964

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472685

90° Infant Offset Plate, 3-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1963
In Commercial Distribution

  • 00840194472685 ()
00-3001-1963

  • Femoral neck fixation plate/sleeve

3P Hip System - 00840194472678

90° Infant Offset Plate, 2-Hole, 6mm Offset
ORTHOPEDIATRICS CORP.
00-3001-1962
In Commercial Distribution

  • 00840194472678 ()
00-3001-1962

  • Femoral neck fixation plate/sleeve

PNP Femur - 00840194472616

13mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0093-S
In Commercial Distribution

  • 00840194472616 ()
01-1501-0093-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472609

12mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0092-S
In Commercial Distribution

  • 00840194472609 ()
01-1501-0092-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472593

11mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0091-S
In Commercial Distribution

  • 00840194472593 ()
01-1501-0091-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472586

10mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0090-S
In Commercial Distribution

  • 00840194472586 ()
01-1501-0090-S

  • Medullary canal orthopaedic reamer shaft

PNP Femur - 00840194472401

PNP Screw Easy Off
ORTHOPEDIATRICS CORP.
01-1501-0076-S
In Commercial Distribution

  • 00840194472401 ()
01-1501-0076-S

  • Surgical screwdriver, single-use

RFS Instrument - E302RFSDI259

RFS™ Driver Insert 2.5mm
Bioretec Oy
RFS-DI25
Not in Commercial Distribution

  • E302RFSDI259 ()
RFS-DI25

  • Surgical screwdriver, reusable

RFS Instrument - E302RFSCHS359

RFS Cannulated Hex Shaft 3.5
Bioretec Oy
RFS-CHS35
Not in Commercial Distribution

  • E302RFSCHS359 ()
RFS-CHS35

  • Surgical screwdriver, reusable

RFS Instrument - E302RFSCHDL9

RFS Cannulated Handle Large
Bioretec Oy
RFS-CHDL
Not in Commercial Distribution

  • E302RFSCHDL9 ()
RFS-CHDL

  • Surgical screwdriver, reusable

RFS Instrument - E302RFSDI359

RFS™ Driver Insert 3.5mm
Bioretec Oy
RFS-DI35
Not in Commercial Distribution

  • E302RFSDI359 ()
RFS-DI35

  • Surgical screwdriver, reusable

RFS Instrument - E302RFSCHS259

RFS Cannulated Hex Shaft 2.5
Bioretec Oy
RFS-CHS25
Not in Commercial Distribution

  • E302RFSCHS259 ()
RFS-CHS25

  • Surgical screwdriver, reusable

JEDMED - M6335004000

MALLET 400GR
JEDMED INSTRUMENT COMPANY
50-0400
In Commercial Distribution

  • M6335004000 ()
50-0400

  • Surgical mallet

JEDMED - M6335003200

MALLET 320GR
JEDMED INSTRUMENT COMPANY
50-0320
In Commercial Distribution

  • M6335003200 ()
50-0320

  • Surgical mallet

JEDMED - M6335001400

MALLET 140GR
JEDMED INSTRUMENT COMPANY
50-0140
In Commercial Distribution

  • M6335001400 ()
50-0140

  • Surgical mallet

JEDMED - M6335001000

MALLET 100GR
JEDMED INSTRUMENT COMPANY
50-0100
In Commercial Distribution

  • M6335001000 ()
50-0100

  • Surgical mallet
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